CAEBVPhase 2NCT04518982
Sintilimab and Lenalidomide as a Treatment for CAEBV
A Phase 2 study testing Sintilimab and lenalidomide in people with CAEBV, run by Zhao Wang at 1 site in China.
Trial summary
This study is a multi-center, prospective, randomized, controlled clinical study to evaluate the effectiveness of a combination regimen of Sintilimab and lenalidomide in patients with chronic active EBV infection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- CAEBV
- What is being tested?
- Sintilimab and lenalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 1 Aug 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with CAEBV confirmed by WHO criteria.
- The Eastern United States Oncology Cooperative group (ECOG) Physical Status score is 0 or 1.
- Before the study, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3× normal upper limit (ULN); Total bilirubin ≤2 times the normal upper limit; Serum creatinine ≤1.5 times the normal value.
- Absolute neutrophil count ≥1×109/L; Platelet ≥50×109/L; Hemoglobin ≥60 g/L.
- International standardized ratio ≤2.0, prothrombin time ≤1.5×ULN.
- A woman of childbearing age must be determined not to be pregnant by a pregnancy test and is willing to take effective measures to prevent pregnancy during the trial period and ≥12 months after the last administration of the drug; All male subjects used contraceptive methods during the study period and ≥6 months after the last administration;
- Sign the informed consent.
Who cannot join
- There is evidence that EBV is associated with hematologic disease or malignancy, such as hemophagocytic syndrome, lymphoma-like granulomatosis, post-transplant lymphoproliferative disease, non-Hodgkin's lymphoma, Burkitt lymphoma, nasopharyngeal cancer, and gastric cancer.
- Symptomatic EBV-associated diseases of the major organs, including the central nervous system and lungs.
- Abnormal thyroid function.
- Patients with grade II or above heart disease (including grade II) were identified according to the New York Heart Association (NYHA) score.
- Have received any of the following treatments: PD-1 antibody, PD-L1 antibody or lenalidomide; Received any research drug within 12 weeks prior to the first use of the study drug; Another clinical study was also included.
- Other primary malignancies occur within 5 years before the first administration of the drug, except those that are locally curable after radical treatment (such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma of the prostate, cervix or breast in situ, etc.).
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- A history of organ transplantation (such as liver transplantation, kidney transplantation, etc.).
- Hematopoietic stem cell transplantation is expected during the study period.
- Active hepatitis B (defined as hepatitis B surface antigen [HBsAg] positive during screening, or hepatitis B virus DNA titer test in peripheral blood greater than 1×103 copies/ml), and active hepatitis C (defined as hepatitis C antibody [HCV-AB] and HCV-RNA positive during screening). Serum HIV antigen or antibody positive. A history of syphilis.
- Had major surgery within 4 weeks prior to the first medication or was expected to require major surgery during the study period.
- Pregnant and lactating women;
- A history of serious mental illness or drug abuse;
- Uncontrollable infections (including lung infections, intestinal infections, etc.); Internal organ active massive hemorrhage (including gastrointestinal hemorrhage, alveolar hemorrhage, intracranial hemorrhage, etc.);
- Allergic to the test drug ingredients or to a more severe allergic constitution;
- Patients who cannot comply during the trial and/or follow-up phase.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing
jingshi wang, 86-010-63139862, wangjingshi987@126.com
About this study
Official title: Sintilimab and Lenalidomide as a Treatment for CAEBV：a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
This study is a multi-center, prospective, randomized, controlled clinical study to evaluate the effectiveness of a combination regimen of Sintilimab and lenalidomide in patients with chronic active EBV infection.
- Conditions
- CAEBV
- Being tested
- Sintilimab and lenalidomide, Sintilimab placebo and lenalidomide placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sintilimab and lenalidomideDrug
Drug: Sintilimab 200mg ivgtt on day 1. Drug: lenalidomide 10mg orally once a day, day 1-14.
Sintilimab placebo and lenalidomide placeboDrug
Drug: Sintilimab placebo ivgtt on day 1. Drug: lenalidomide placebo orally once a day, day 1-14.
| Study group | Role | What they receive |
|---|---|---|
| The experimental group | Experimental | Not described Receives: Drug: Sintilimab and lenalidomide |
| The control group | Placebo comparator | Not described Receives: Drug: Sintilimab placebo and lenalidomide placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
The rate of decline in ebV-DNA copy (defined as a 2log decrease in EBV-DNA copy) or negative rate in peripheral blood mononuclear cells and plasma
Measured: Twelve weeks after treatment
Secondary outcomes (5)
Spleen size
Measured: Twelve weeks after treatment
T and B lymphocyte subsets
Measured: Twelve weeks after treatment
Pathological tissue or bone marrow
Measured: Twelve weeks after treatment
treatment-related adverse events as assessed by CTCAE v4.0
Adverse events including thyroid function， liver function damage, myelosuppression, infection, bleeding and so on.
Measured: through study completion, an average of 1 years
survival
From enrollment until death or the end of the experiment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start1 Aug 2020
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CAEBVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhao Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhao Wang, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518982
- Sponsor's protocol ID
- Sintilimab,Lenalidomide,CAEBV
- Status last verified
- Aug 2020
- First submitted
- 16 Aug 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sintilimab and Lenalidomide as a Treatment for CAEBV：a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04518982
- Acronym / sponsor ID
- Sintilimab,Lenalidomide,CAEBV
- Conditions
- CAEBV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Zhao WangUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 19 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multi-center, prospective, randomized, controlled clinical study to evaluate the effectiveness of a combination regimen of Sintilimab and lenalidomide in patients with chronic active EBV infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group | Experimental | Drug: Sintilimab and lenalidomide |
| The control group | Placebo comparator | Drug: Sintilimab placebo and lenalidomide placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with CAEBV confirmed by WHO criteria.
- The Eastern United States Oncology Cooperative group (ECOG) Physical Status score is 0 or 1.
- Before the study, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3× normal upper limit (ULN); Total bilirubin ≤2 times the normal upper limit; Serum creatinine ≤1.5 times the normal value.
- Absolute neutrophil count ≥1×109/L; Platelet ≥50×109/L; Hemoglobin ≥60 g/L.
- International standardized ratio ≤2.0, prothrombin time ≤1.5×ULN.
Key exclusion criteria (15 listed)
- There is evidence that EBV is associated with hematologic disease or malignancy, such as hemophagocytic syndrome, lymphoma-like granulomatosis, post-transplant lymphoproliferative disease, non-Hodgkin's lymphoma, Burkitt lymphoma, nasopharyngeal cancer, and gastric cancer.
- Symptomatic EBV-associated diseases of the major organs, including the central nervous system and lungs.
- Abnormal thyroid function.
- Patients with grade II or above heart disease (including grade II) were identified according to the New York Heart Association (NYHA) score.
- Have received any of the following treatments: PD-1 antibody, PD-L1 antibody or lenalidomide; Received any research drug within 12 weeks prior to the first use of the study drug; Another clinical study was also included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sintilimab and lenalidomideDrug: Sintilimab 200mg ivgtt on day 1. Drug: lenalidomide 10mg orally once a day, day 1-14. | Drug | The experimental group |
| Sintilimab placebo and lenalidomide placeboDrug: Sintilimab placebo ivgtt on day 1. Drug: lenalidomide placebo orally once a day, day 1-14. | Drug | The control group |
Primary outcome
Response rate
Time frame: Twelve weeks after treatment
The rate of decline in ebV-DNA copy (defined as a 2log decrease in EBV-DNA copy) or negative rate in peripheral blood mononuclear cells and plasma
5 secondary outcomes
Spleen size
Time frame: Twelve weeks after treatment
T and B lymphocyte subsets
Time frame: Twelve weeks after treatment
Pathological tissue or bone marrow
Time frame: Twelve weeks after treatment
treatment-related adverse events as assessed by CTCAE v4.0
Time frame: through study completion, an average of 1 years
survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sintilimab and lenalidomide in people with CAEBV, run by Zhao Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jingshi wang (86-010-63139862, wangjingshi987@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: Twelve weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2020.